Cleanroom & HEPA Certification Specialist

Role Summary

Cleanroom & HEPA Certification Specialist responsible for coordinating preventive maintenance and on-demand certification activities to support manufacturing operations. Ensures timely certifications of HEPA-filtered areas and equipment, maintains documentation, and supports audits.

Responsibilities

• Planning and scheduling outside contractors/vendors to perform scheduled and/or non-scheduled preventive maintenance or general work
• Collaborating with Certification Vendors and Facilities, Manufacturing, and Lab Management Scheduling Groups to ensure timely certifications of HEPA-filtered areas and equipment
• Recording certification activities in electronic records
• Maintaining safe and efficient operation of Cleanroom and HEPA equipment and related support equipment in accordance with SOPs, cGMPs, and quality standards
• Managing vendor documentation files (hardcopy and electronic)
• Collecting, trending, and analyzing HEPA filter data
• Identifying areas for improvement and implementing proactive program enhancements
• Participating as a Subject Matter Expert (SME) in creating and revising Procedures and Work Instructions and supporting Regulatory and Partner Audits as an SME

Qualifications

• Required: BA/BS degree or equivalent combination of education and experience, preferably in Engineering or Construction Technologies; minimum experience in CMMS and HEPA Filtration or HVAC Systems (Specific levels below)
• Specialist: 2+ years
• Senior Specialist: 5+ years
• Prior experience in Cleanroom and HEPA Certification or HVAC preferred

Skills

• Strong written and verbal communication skills
• Ability to build and maintain positive working relationships with the business
• Effective time management to meet timelines
• Experience with electronic work record systems (Blue Mountain Regulatory Asset Manager preferred but not required)
• Gowning experience for entering and working in Cleanroom environments
• Experience in Cleanroom, ISO Classifications, HEPA Filtration or HVAC Systems
• Proficiency with Microsoft Office Suite and general computer systems

Education

• BA/BS degree or equivalent; preferred in Engineering or Construction Technologies; relevant certification/experience in CMMS and HEPA Filtration or HVAC Systems

Additional Requirements

• On-site work requirements may apply; discuss location with recruiter/hiring manager
• Background checks as part of recruitment process